Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001404112
Ethics application status
Not required
Date submitted
29/09/2019
Date registered
14/10/2019
Date last updated
14/10/2019
Date data sharing statement initially provided
14/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic Mucosal Resection For People with Colonic Polyps.
Scientific title
The Safety and Efficacy of Endoscopic Mucosal Resection for Large Polyps at Middlemore Hospital
Secondary ID [1] 299438 0
None
Universal Trial Number (UTN)
U1111-1241-1854
Trial acronym
MEMORY study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Removal of colonic polyps 314638 0
Condition category
Condition code
Oral and Gastrointestinal 312979 312979 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 313052 313052 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To perform a comprehensive review of our Endoscopic Submucosal Resection (EMR) practice, in particular to determine the safety, efficacy and outcomes, including polyp recurrence at our institution for polyps greater than 20mm undergoing EMR.

The primary outcome will be establishing the proportion of patients who have bleeding and/or perforation.

In addition, we wish to define risk factors for both complication and failed/unsuccessful EMR (defined as initial incomplete removal OR recurrence at scheduled surveillance follow-up).

Participants will not be required to perform any additional tasks in this study. The total duration of observation for the study will be 1 year post the date of the procedure.

All patients in this study will receive usual standard of care practice with EMR - there will be no alteration in practice or data collected.
Intervention code [1] 315686 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321546 0
The primary outcome will be establishing the proportion of patients who have bleeding and/or perforation.
This outcome will be assessed real-time (i.e. perforation recorded if this occurred during the procedure) and via collection of medical records for bleeding (i.e. if admitted to hospital for this).
Timepoint [1] 321546 0
Within 1 month of the procedure
Secondary outcome [1] 375330 0
Rate of polyp recurrence (observed endoscopically)
Timepoint [1] 375330 0
12 months post procedure (usually at the time of next procedure for surveillance).

Eligibility
Key inclusion criteria
Consecutive patients undergoing an EMR of a non-pedunculated lesion >20mm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incomplete data only

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size is estimated based on the primary objective of establishing the proportion of patients who have bleeding and/or perforation, at approximately 3%. Accordingly, we will aim to recruit 250 patients (mid-p) based on wanting width of 95% confidence interval to be no greater than 0.05.
Although this selected sample size does not give power to identify minor risk factors, for practical reasons a larger sample size is not possible and analysis of risk factors will only be exploratory.

95% Confidence intervals will be calculated for the estimate of the primary outcome..

Logistic regression will be performed to identify significant risk factors, Firth’s penalised regression will be used in case of sparse data. The analysis will be performed as a per-protocol principle. Significance is considered at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
1/11/2021
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 21892 0
New Zealand
State/province [1] 21892 0
Auckland

Funding & Sponsors
Funding source category [1] 303946 0
Hospital
Name [1] 303946 0
Middlemore Hospital
Country [1] 303946 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
100 Hospital Rd, Otahuhu, Auckland 2025, New Zealand
Country
New Zealand
Secondary sponsor category [1] 304101 0
None
Name [1] 304101 0
Address [1] 304101 0
Country [1] 304101 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 304446 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 304446 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304446 0
New Zealand
Date submitted for ethics approval [1] 304446 0
30/09/2019
Approval date [1] 304446 0
Ethics approval number [1] 304446 0
9/NTA/143

Summary
Brief summary
Endoscopic mucosal resection (EMR) has become the primary therapy in the management of large polyps in the colon. It is now the standard of care for safe and effective resection of large (greater than 20mm) non-pedunculated polyps. We aim to perform a comprehensive review of our EMR practice, in particular to determine the safety, efficacy and outcomes, including polyp recurrence at our institution for polyps greater than 20mm undergoing EMR.
Trial website
Nil
Trial related presentations / publications
Public notes
HDEC "out of scope" letter recieved 04/10/2019.

Contacts
Principal investigator
Name 96970 0
Dr Anurag Sekra
Address 96970 0
C/O Gastroenterology Department
100 Hospital Rd, Otahuhu, Auckland 2025, New Zealand
Country 96970 0
New Zealand
Phone 96970 0
+649276 0044
Fax 96970 0
Email 96970 0
[email protected]
Contact person for public queries
Name 96971 0
Dr Anurag Sekra
Address 96971 0
C/O Gastroenterology Department
100 Hospital Rd, Otahuhu, Auckland 2025, New Zealand
Country 96971 0
New Zealand
Phone 96971 0
+649276 0044
Fax 96971 0
Email 96971 0
[email protected]
Contact person for scientific queries
Name 96972 0
Dr Cameron Schauer
Address 96972 0
C/O Gastroenterology Department
100 Hospital Rd, Otahuhu, Auckland 2025, New Zealand
Country 96972 0
New Zealand
Phone 96972 0
+649276 0044
Fax 96972 0
Email 96972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.